Surgery and injury typically generate swelling and bruising about the injured area. Currently, it is common practice to treat this injured area with ice or other forms of cold therapy. Indeed, cooling an injured area is thought to decrease blood flow, edema, hemorrhaging, inflammation, muscle spasms, and pain. In addition, cooling an injured area often serves to provide temporary relief to a subject. There are a number of ways currently used to cool down an injured area. For example, freezer-based devices such as ice and gel-packs may be used. Continuous cold therapy devices may also be used, and may have advantages over freezer-based devices. Continuous cold therapy devices typically consist of a thin pad that is placed on the affected body area through which cold water is circulated. Some of these solutions are ice-based and some of them employ refrigeration means to produce the temperature change. However, both freezer-based solutions and continuous cold therapy devices may be limited by shortcomings reflected in their effectiveness and popularity, especially when used after plastic surgery or for application on the face.
Freezer-based devices such as ice packs and gel packs may have a number of characteristics which limit their effectiveness. For example, freezer-based devices are typically held at temperatures below freezing, which may be too cold for continuous use on the skin. The cold temperature may cause frostbite and in extreme cases can result in dermal necrosis. To reduce this risk, it is recommended that ice is applied 20 minutes on and 20 minutes off. Another shortcoming is that it may be difficult to for the devices to conform to complex shapes such as those found on the knee, hand, face or shoulder. The thickness of the device may limit the flexibility and the ability of the pad to conform to affected area. If the thickness is reduced, this typically reduces the ability of the pad to absorb heat, which limits the time that the device will remain in a therapeutic range. Freezer-based devices may also be difficult to secure comfortably on the body due to their size and weight. Thus, the effective use of freezer-based devices may require constant patient interaction in order for the devices to be used effectively, thereby limiting the activities that can be done while applying the therapy. For example, it may be difficult to sleep and perform other activities while ensuring that a uniform, constant therapy is being applied.
Continuous cold therapy devices may improve upon freezer-based devices by automating the cooling process. The systems may consist of a therapeutic pad that is placed on the body and a cooling unit which circulates cold water though the pad. Some versions of these devices use ice to absorb the heat and provide the cooling. Fully electric systems using thermoelectric modules are also available.
Ice-based cooling devices may have significantly improved performance compared to freezer-based solutions. However, because they use ice, ice-based cooling devices must be constantly emptied and refilled with ice. The device can be heavy, and the re-filling process can be difficult, especially for someone who has an injury or is recovering from surgery. Also, because the devices may consume more ice than is readily available from a home freezer, a user may have to purchase ice to use the ice-based cooling devices. The devices may also be difficult to maintain at a desired therapeutic temperature, and the ice bath may pose an increased risk of frostbite and tissue damage if the low-end temperature is not properly regulated. As the ice melts, the temperature may also rise, which limits the control and repeatability of the temperature management and the effectiveness of the therapy. A thermoelectric, continuous cold therapy device may solve some of these shortcomings.
A thermoelectric device may use electricity to dissipate body heat and to cool circulating water. The temperature of a thermoelectric device can be easily regulated by electronic or mechanical means and offers a safe, repeatable therapy for patient recovery. Historically, thermoelectric units have been too expensive to be popular home appliances and have mostly been limited to hospital and clinic applications.
Ice-based continuous cold therapy devices and pads have achieved most of their commercial success in the field of orthopedic recovery. For application in other disciplines such as cosmetic surgery, the devices may have several shortcomings. Many cold therapy pads may not provide direct contact to an injured area. Furthermore, many cold therapy devices may not conform closely to an injured area. This concern is of particular importance in areas such as cosmetic surgery where the injured body part, or parts, are typically irregularly shaped (e.g., the eyes, nose, neck, breasts, ears, etc.). In addition, it may be particularly important, especially on the face, to reduce the wrinkling of the pad and other points of pressure concentration that may be uncomfortable to users. The comfort demands for the face are much higher than they are for less sensitive parts of the body. The temperature range of acceptable therapy temperatures may be much stricter for facial applications than for other cold-therapy applications. The risk of frostbite, dermal necrosis and other tissue damage should be minimized or eliminated to assure patients and doctors that the therapy is safe.
In many cosmetic surgery procedures, it can be of great importance to stabilize the injured area (e.g., to maintain facial bones in place, secure skin flaps). For example, nose splints have been developed to maintain pressure on precise areas of the nose to control swelling or distortion of the nose, which can disrupt the normal healing process, and potentially lead to less than desirable cosmetic results. Splints for these purposes have been developed from metals, plasters and the like.
Accordingly, it would be desirable to have improved devices for application to, and treatment of, an injured area. Similarly, it would be desirable to have flexible, moldable and settable devices capable of cooling an injured area, yet that have sufficient structure and strength to provide adequate pressure and stability to the injured area. It would also be desirable to have devices that allow for continuous temperature control and adjustment. In a like fashion, devices that can be applied to an injured area immediately after surgery, and be continuously worn and used at home, would be desirable.